Clinical Project Manager

Hi

My name is Karthik Mutyala and Im a Recruitment Manager with Stark Pharma Solutions Inc specializing in pharmaceutical biotechnology and medical device roles. I came across your profile and wanted to see if you are open to new opportunities.

If interested please send me your updated resume along with the best number and time to reach you.

Job title: Clinical Project Manager

Location: Skaneateles NY

Duration: 4 Months

Summary:

Responsible for managing the organization and conduct of clinical studies in compliance with Clinical Operations policies and procedures Regulatory (Health) Authority requirements and guidelines and International Conference on Harmonization (ICH) Guidelines in support of global business objectives.

Reports directly to Sr. Director of Medical Affairs. The Clinical Project Manager plans for and executes the required global or domestic clinical development plan of drugs and devices to generate data to support the launch and expansion of critical treatments for patients. This data serves to globally support regulatory submissions post-marketing complaint handling and promotional claims for marketing strategies.

This role also partners cross-functionally with regulatory engineering marketing sales and research teams to support problem-solving and decision-making efforts.

Top skills needed:

• 4 5 years of clinical research experience including 1 2 years as a Clinical Project Manager
• Proactive collaborative and self-driven with a take-charge attitude
• End-to-end clinical study experience (site selection contracting execution and closeout)

Essential Duties and Responsibilities:

• Partner with relevant Baxter functions to develop clinical study plan for each project including timelines and budgets for the clinical program.
• Prepare directly or facilitate preparation of study documentation including protocols case report forms informed consent enrolment feasibility evaluations and all relevant internal plans required for study conduct.
• CRO management (when applicable): Lead the day-to-day oversight of the CRO personnel plus the project budget deliverables and timeline/milestones.
• Site activities (either directly or managing others): Identify and assess study sites conduct investigator meetings and site training prepare and execute research agreements and negotiate study budgets.
• Study monitoring (either directly or managing others): Formulate clinical monitoring plan perform study initiation visits manage clinical study monitoring resources oversee standard interim monitoring visits and closeout activities
• Perform study closeout procedures directly or through other resources including accurate completion of critical documents disposition of study product and preparation of study sites for regulatory authority audits.
• Develop and maintain tracking systems as needed for study management e.g. screening enrolment study completion (serious) adverse events budgets and forecasts milestones.

Qualifications Education and Experience

• Bachelors degree in a scientific field
• Minimum 5 years of clinical operations experience (pharma biotech or medical device)
• 1 2 years of direct Clinical Project Manager experience preferred
• Knowledge of FDA ICH/GCP and global regulatory requirements
• Understanding of clinical trial phases (Phase 1 4)
• Experience with clinical systems (EDC CTMS eTMF)
• Strong project management skills
• Knowledge of arrhythmias ECG interpretation or ambulatory cardiac monitoring systems
• Ability to interpret diagnostic performance metrics (e.g. sensitivity specificity PPV/NPV) and translate findings into clinical insights
• Experience assessing risk/benefit and clinical implications of algorithm performance differences
• Familiarity with algorithm-based diagnostics or AI/ML-driven medical devices
• Understanding of validation requirements for medical devices (e.g. EU MDR FDA expectations)